FDA.reportPublic FDA data

diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen]

RxCUI
1020479
RxNorm name
diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen]
Display name
BANOPHEN (Oral Pill)
Full name
diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen]
Term type
SBD
Status
Active
Strength
50 mg
Dose form
Cap
Route
Oral Pill
Updated
2026-07-22 07:05:56

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
112010
Active start
112010
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
diphenhydramine hydrochloride50 MG / 1 EACHdiphenhydraminediphenhydramine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Capsule316965

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
diphenhydramine3498

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRBanophen 50 MG Oral Capsule1NAMES
RxNorm Namediphenhydramine hydrochloride 50 MG Oral Capsule [Banophen]1NAMES
RxNorm SynonymBanophen 50 MG Oral Capsule1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
6 linked values
6CODES
RxCUI10204791CODES
MMSL_CODEBD34061CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0904-5307-600904-5307Banophen diphenhydramine hclMajor PharmaceuticalsM012
0904-5307-800904-5307Banophen diphenhydramine hclMajor PharmaceuticalsM012
63629-9451-263629-9451Banophen diphenhydramine hclBryant Ranch PrepackM012
68071-2611-568071-2611Banophen diphenhydramine hclNuCare Pharmaceuticals,Inc.M022
68788-7830-168788-7830Banophen diphenhydramine hclPreferred Pharmaceuticals Inc.341
68788-7830-368788-7830Banophen diphenhydramine hclPreferred Pharmaceuticals Inc.341
71335-0081-071335-0081Banophen diphenhydramine hclBryant Ranch PrepackM012
71335-0081-171335-0081Banophen diphenhydramine hclBryant Ranch PrepackM012
71335-0081-271335-0081Banophen diphenhydramine hclBryant Ranch PrepackM012
71335-0081-371335-0081Banophen diphenhydramine hclBryant Ranch PrepackM012
71335-0081-471335-0081Banophen diphenhydramine hclBryant Ranch PrepackM012
71335-0081-571335-0081Banophen diphenhydramine hclBryant Ranch PrepackM012
71335-0081-671335-0081Banophen diphenhydramine hclBryant Ranch PrepackM012
71335-0081-771335-0081Banophen diphenhydramine hclBryant Ranch PrepackM012
71335-0081-871335-0081Banophen diphenhydramine hclBryant Ranch PrepackM012
71335-0081-971335-0081Banophen diphenhydramine hclBryant Ranch PrepackM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M0120904-5307Banophen diphenhydramine hclOTC MONOGRAPH DRUGMajor Pharmaceuticals
M02268071-2611Banophen diphenhydramine hclOTC MONOGRAPH DRUGNuCare Pharmaceuticals,Inc.
34168788-7830Banophen diphenhydramine hclOTC MONOGRAPH DRUGPreferred Pharmaceuticals Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 24 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00904530760rxnav_ndcsyes
00904530780rxnav_ndcsyes
55700067830rxnav_ndcsyes
63629945101rxnav_ndcsyes
63629945102rxnav_ndcsyes
68071261105rxnav_ndcsyes
68788783001rxnav_ndcsyes
68788783003rxnav_ndcsyes
71335008100rxnav_ndcsyes
71335008101rxnav_ndcsyes
71335008102rxnav_ndcsyes
71335008103rxnav_ndcsyes
71335008104rxnav_ndcsyes
71335008105rxnav_ndcsyes
71335008106rxnav_ndcsyes
71335008107rxnav_ndcsyes
71335008108rxnav_ndcsyes
71335008109rxnav_ndcsyes
49349093402rxnav_historical
70518128900rxnav_historical
70518128901rxnav_historical
70518144200rxnav_historical
70518144201rxnav_historical
70518144202rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BanophenDIPHENHYDRAMINE HCLBryant Ranch Prepack20f00537-2c8a-45d1-8e5f-ec276d0a47b62026-05-18WarningsExact identifier
ndc (package): 71335-0081-9
ndc (package): 71335-0081-6
ndc (package): 71335-0081-8
ndc (package): 71335-0081-0
ndc (package): 71335-0081-3
ndc (package): 71335-0081-1
ndc (package): 71335-0081-5
ndc (package): 71335-0081-4
ndc (package): 71335-0081-2
ndc (package): 71335-0081-7
ndc (product): 71335-0081
ndc11 (package): 71335008109
ndc11 (package): 71335008102
ndc11 (package): 71335008103
ndc11 (package): 71335008108
ndc11 (package): 71335008101
ndc11 (package): 71335008100
ndc11 (package): 71335008107
ndc11 (package): 71335008106
ndc11 (package): 71335008104
ndc11 (package): 71335008105
rxcui: 1020479
BanophenDIPHENHYDRAMINE HCLPreferred Pharmaceuticals Inc.0f52270a-b11a-4fa1-aac2-9fe5ff6254192026-04-06WarningsExact identifier
ndc (package): 68788-7830-3
ndc (package): 68788-7830-1
ndc (product): 68788-7830
ndc11 (package): 68788783001
ndc11 (package): 68788783003
rxcui: 1020479
BanophenDIPHENHYDRAMINE HCLMajor Pharmaceuticals7f2b72cc-d4f7-431f-be61-c103cf8c489e2026-02-20WarningsExact identifier
ndc (package): 0904-5307-60
ndc (package): 0904-5307-80
ndc (product): 0904-5307
ndc11 (package): 00904530760
ndc11 (package): 00904530780
rxcui: 1020479

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 6 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
d0f4b9f4-e727-4d47-b156-7bcdcb1606daBANOPHEN 50 MG Oral Capsule [PSN] · diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen] [SBD] · Banophen 50 MG Oral Capsule [SY]31060836-Major(100C/1000C)20260424
20f00537-2c8a-45d1-8e5f-ec276d0a47b6BANOPHEN 50 MG Oral Capsule [PSN] · diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen] [SBD] · Banophen 50 MG Oral Capsule [SY]3110836-Major(100C/1000C)20260518
7f2b72cc-d4f7-431f-be61-c103cf8c489eBANOPHEN 50 MG Oral Capsule [PSN] · diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen] [SBD] · Banophen 50 MG Oral Capsule [SY]3100836-Major(100C/1000C)20260220
0e06dca9-485a-4367-bcfa-07e0cc27c128BANOPHEN 50 MG Oral Capsule [PSN] · diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen] [SBD] · Banophen 50 MG Oral Capsule [SY]37Banophen20171107
0f52270a-b11a-4fa1-aac2-9fe5ff625419BANOPHEN 50 MG Oral Capsule [PSN] · diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen] [SBD] · Banophen 50 MG Oral Capsule [SY]350836-Major(100C/1000C)20260406
d4ec6dfd-61b0-7153-e053-2995a90ad88fBANOPHEN 50 MG Oral Capsule [PSN] · diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen] [SBD] · Banophen 50 MG Oral Capsule [SY]320836-Major(100C/1000C)20241212

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
20f00537-2c8a-45d1-8e5f-ec276d0a47b60836-Major(100C/1000C)Bryant Ranch Prepack20260518
d0f4b9f4-e727-4d47-b156-7bcdcb1606da0836-Major(100C/1000C)Bryant Ranch Prepack20260424
0f52270a-b11a-4fa1-aac2-9fe5ff6254190836-Major(100C/1000C)Preferred Pharmaceuticals Inc.20260406
7f2b72cc-d4f7-431f-be61-c103cf8c489e0836-Major(100C/1000C)Major Pharmaceuticals20260220
d4ec6dfd-61b0-7153-e053-2995a90ad88f0836-Major(100C/1000C)NuCare Pharmaceuticals,Inc.20241212
5340773c-688d-45fd-85a2-75f8589f303d0836-Major(100C/1000C)REMEDYREPACK INC.20220916
28a98e8d-98c9-4e7c-b978-b567cb280f940836-Major(100C/1000C)REMEDYREPACK INC.20220914
8062efc9-656a-4ca7-9d0a-55ecb16adb7fBanophenLake Erie Medical DBA Quality Care Products LLC20210517
602b6862-e0e7-4d9b-bcb4-48a7a3eba316National Council for Prescription Drug Programs20130211
fbc100c3-1d2e-4360-bd2f-a92b1e556d3bNational Council for Prescription Drug Programs20130211

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCR06AAAminoalkyl ethersATC1-4diphenhydramine
ATCD04AAAntihistamines for topical useATC1-4diphenhydramine
FDASPLN0000175587Histamine-1 Receptor AntagonistEPChas_epcdiphenhydramine
FDASPLN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine
MEDRTD004155DiphenhydramineCHEMhas_ingredientdiphenhydramine hydrochloride
MEDRTD004155DiphenhydramineCHEMhas_ingredientdiphenhydramine
MEDRTD001008Anxiety DisordersDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD001008Anxiety DisordersDISEASEmay_treatdiphenhydramine
MEDRTD004342Drug HypersensitivityDISEASEci_withdiphenhydramine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withdiphenhydramine
MEDRTD007231Infant, NewbornDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007231Infant, NewbornDISEASEci_withdiphenhydramine
MEDRTD007234Infant, PrematureDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007234Infant, PrematureDISEASEci_withdiphenhydramine
MEDRTD007774LactationDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007774LactationDISEASEci_withdiphenhydramine
MEDRTD009041Motion SicknessDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD009041Motion SicknessDISEASEmay_treatdiphenhydramine
MEDRTD009325NauseaDISEASEmay_treatdiphenhydramine
MEDRTD009325NauseaDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdiphenhydramine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdiphenhydramine
MEDRTD012912SneezingDISEASEmay_treatdiphenhydramine
MEDRTD012912SneezingDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD013224Status AsthmaticusDISEASEci_withdiphenhydramine
MEDRTD013224Status AsthmaticusDISEASEci_withdiphenhydramine hydrochloride
MEDRTD014581UrticariaDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD014581UrticariaDISEASEmay_treatdiphenhydramine
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine hydrochloride
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH50 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
NAMESPrescribable SynonymBANOPHEN 50 MG Oral Capsule
NAMESTallman SynonymdiphenhydrAMINE hydrochloride 50 MG Oral Capsule [Banophen]
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon